Ready-to-use bivalirudin compositions
AssigneeMaia Pharmaceuticals, Inc.
InventorSrikanth Sundaram
Life of this patent
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Abstract
Ready-to-use liquid bivalirudin compositions, methods of using the ready-to-use bivalirudin compositions, and methods of preparing the ready-to-use liquid bivalirudin compositions are provided herein. The liquid ready-to-use bivalirudin compositions comprise a pharmaceutically acceptable amount of bivalirudin.
Claims21
A method of inhibiting blood clots in a patient in need thereof comprising intravenously administering to the patient a therapeutically effective amount of a ready-to-use liquid composition comprising about 5 mg/mL bivalirudin or a salt thereof, about 0.8 mg/mL sodium acetate, about 100 mg/mL PEG 400, and water and optionally, glacial acetic acid and/or sodium hydroxide, wherein
- the ready-to-use liquid composition is prepared by a method that comprises mixing bivalirudin or salt thereof, sodium acetate, PEG 400, and water and optionally glacial acetic acid and/or sodium hydroxide to form the ready-to-use liquid composition,
- the composition is stored at 2-8° C. prior to administration, and
- the composition has a pH of from greater than 5.0 to 5.7.
A method of inhibiting blood clots in a patient in need thereof comprising intravenously administering to the patient a therapeutically effective amount of a ready-to-use liquid composition comprising about 5 mg/mL bivalirudin or a salt thereof, about 0.8 mg/mL sodium acetate trihydrate, about 100 mg/mL PEG 400, and water, wherein
- the ready-to-use liquid composition is prepared by a method that comprises mixing bivalirudin or salt thereof, sodium acetate, PEG 400, and water,
- the composition does not comprise sodium chloride or dextrose, and
- the composition has a pH of from greater than 5.0 to 5.7.
A method of inhibiting blood clots in a patient in need thereof comprising intravenously administering to the patient a therapeutically effective amount of a ready-to-use liquid composition comprising about 5 mg/mL (free base basis) of bivalirudin trifluoroacetate, about 0.8 mg/mL sodium acetate trihydrate, about 100 mg/mL PEG 400, and water, wherein
- the composition is prepared by mixing the bivalirudin trifluoroacetate, sodium acetate, PEG 400, and water,
- the composition is free of sodium chloride and dextrose,
- the composition has a pH of from greater than 5.0 to 5.7, and
- the percentage of total impurities increases by no more than about 9% from the time of manufacture of the composition up to 12 months of storage at 5° C. as determined by high performance liquid chromatography at a wavelength of 215 nm.
Dependencies are inferred from the claim text.